The 2014 Florida Statutes

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The 2014 Florida Statutes

Title XXXII REGULATION OF PROFESSIONS AND OCCUPATIONS

CHAPTER 465 PHARMACY

Chapter 465 View Entire Chapter PHARMACY

465.001 Short Title. 465.002 Legislative findings; intent. 465.003 Definitions. 465.004 Board of Pharmacy. 465.005 Authority to make rules. 465.006 Disposition of fees; expenditures. 465.007 Licensure by examination. 465.0075 Licensure by endorsement; requirements; fee. 465.008 Renewal of license. 465.009 Continuing professional pharmaceutical education. 465.012 Reactivation of license; continuing education. 465.0125 Consultant pharmacist license; application, renewal, fees; responsibilities; rules. 465.0126 Nuclear pharmacist license; application, renewal, fees. 465.013 Registration of pharmacy interns. 465.014 Pharmacy technician. 465.015 Violations and penalties. 465.0155 Standards of practice. 465.0156 Registration of nonresident pharmacies. 465.0158 Nonresident sterile compounding permit. 465.016 Disciplinary actions. 465.0161 Distribution of medicinal drugs without a permit. 465.017 Authority to inspect; disposal. 465.018 Community pharmacies; permits. 465.0181 Community pharmacy permit required to dispense Schedule II or Schedule III controlled substances. 465.019 Institutional pharmacies; permits. 465.0193 Nuclear pharmacy permits. 465.0196 Special pharmacy permits. 465.0197 Internet pharmacy permits. 465.022 Pharmacies; general requirements; fees. 465.023 Pharmacy permittee; disciplinary action. 465.0235 Automated pharmacy systems used by long-term care facilities, hospices, or state

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correctional institutions. 465.024 Promoting sale of certain drugs prohibited. 465.0244 Information disclosure. 465.025 Substitution of drugs. 465.0251 Generic drugs; removal from formulary under specified circumstances. 465.0252 Substitution of interchangeable biosimilar products. 465.0255 Expiration date of medicinal drugs; display; related use and storage instructions. 465.026 Filling of certain prescriptions. 465.0265 Centralized prescription filling. 465.0266 Common database. 465.027 Exceptions. 465.0275 Emergency prescription refill. 465.0276 Dispensing practitioner. 465.035 Dispensing of medicinal drugs pursuant to facsimile of prescription. 465.185 Rebates prohibited; penalties. 465.186 Pharmacist's order for medicinal drugs; dispensing procedure; development of formulary. 465.187 Sale of medicinal drugs. 465.188 Medicaid audits of pharmacies. 465.1885 Pharmacy audits; rights. 465.189 Administration of vaccines and epinephrine autoinjection. 465.1901 Practice of orthotics and pedorthics.

465.001 Short Title.-- This chapter shall be known as the "Florida Pharmacy Act."

History.--ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 26, 27, ch. 86-256; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91429.

465.002 Legislative findings; intent.--The Legislature finds that the practice of pharmacy is a learned profession. The sole legislative purpose for enacting this chapter is to ensure that every pharmacist practicing in this state and every pharmacy meet minimum requirements for safe practice. It is the legislative intent that pharmacists who fall below minimum competency or who otherwise present a danger to the public shall be prohibited from practicing in this state.

History.--ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 1, 26, 27, ch. 86-256; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91429.

465.003 Definitions.--As used in this chapter, the term: (1) "Administration" means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption. (2) "Board" means the Board of Pharmacy. (3) "Consultant pharmacist" means a pharmacist licensed by the department and certified as a consultant pharmacist pursuant to s. 465.0125. (4) "Data communication device" means an electronic device that receives electronic information from one source and transmits or routes it to another, including, but not limited to, any such bridge, router, switch, or gateway. (5) "Department" means the Department of Health. (6) "Dispense" means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. As an element of dispensing, the pharmacist

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shall, prior to the actual physical transfer, interpret and assess the prescription order for potential adverse reactions, interactions, and dosage regimen she or he deems appropriate in the exercise of her or his professional judgment, and the pharmacist shall certify that the medicinal drug called for by the prescription is ready for transfer. The pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of her or his professional judgment counseling is necessary. The actual sales transaction and delivery of such drug shall not be considered dispensing. The administration shall not be considered dispensing.

(7) "Institutional formulary system" means a method whereby the medical staff evaluates, appraises, and selects those medicinal drugs or proprietary preparations which in the medical staff's clinical judgment are most useful in patient care, and which are available for dispensing by a practicing pharmacist in a Class II institutional pharmacy.

(8) "Medicinal drugs" or "drugs" means those substances or preparations commonly known as "prescription" or "legend" drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined.

(9) "Patent or proprietary preparation" means a medicine in its unbroken, original package which is sold to the public by, or under the authority of, the manufacturer or primary distributor thereof and which is not misbranded under the provisions of the Florida Drug and Cosmetic Act.

(10) "Pharmacist" means any person licensed pursuant to this chapter to practice the profession of pharmacy.

(11)(a) "Pharmacy" includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, and an Internet pharmacy.

1. The term "community pharmacy" includes every location where medicinal drugs are compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an outpatient basis.

2. The term "institutional pharmacy" includes every location in a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility, or other facility, hereinafter referred to as "health care institutions," where medicinal drugs are compounded, dispensed, stored, or sold.

3. The term "nuclear pharmacy" includes every location where radioactive drugs and chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or sold. The term "nuclear pharmacy" does not include hospitals licensed under chapter 395 or the nuclear medicine facilities of such hospitals.

4. The term "special pharmacy" includes every location where medicinal drugs are compounded, dispensed, stored, or sold if such locations are not otherwise defined in this subsection.

5. The term "Internet pharmacy" includes locations not otherwise licensed or issued a permit under this chapter, within or outside this state, which use the Internet to communicate with or obtain information from consumers in this state and use such communication or information to fill or refill prescriptions or to dispense, distribute, or otherwise engage in the practice of pharmacy in this state. Any act described in this definition constitutes the practice of pharmacy as defined in subsection (13).

(b) The pharmacy department of any permittee shall be considered closed whenever a Florida licensed pharmacist is not present and on duty. The term "not present and on duty" shall not be construed to prevent a pharmacist from exiting the prescription department for the purposes of consulting or responding to inquiries or providing assistance to patients or customers, attending to personal hygiene needs, or performing any other function for which the pharmacist is responsible, provided that such activities are conducted in a manner consistent with the pharmacist's responsibility to provide pharmacy services.

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(12) "Pharmacy intern" means a person who is currently registered in, and attending, a duly accredited college or school of pharmacy, or who is a graduate of such a school or college of pharmacy, and who is duly and properly registered with the department as provided for under its rules.

(13) "Practice of the profession of pharmacy" includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug; consulting concerning therapeutic values and interactions of patent or proprietary preparations, whether pursuant to prescriptions or in the absence and entirely independent of such prescriptions or orders; and other pharmaceutical services. For purposes of this subsection, "other pharmaceutical services" means the monitoring of the patient's drug therapy and assisting the patient in the management of his or her drug therapy, and includes review of the patient's drug therapy and communication with the patient's prescribing health care provider as licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or similar statutory provision in another jurisdiction, or such provider's agent or such other persons as specifically authorized by the patient, regarding the drug therapy. However, nothing in this subsection may be interpreted to permit an alteration of a prescriber's directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the practice of osteopathic medicine, unless otherwise permitted by law. "Practice of the profession of pharmacy" also includes any other act, service, operation, research, or transaction incidental to, or forming a part of, any of the foregoing acts, requiring, involving, or employing the science or art of any branch of the pharmaceutical profession, study, or training, and shall expressly permit a pharmacist to transmit information from persons authorized to prescribe medicinal drugs to their patients. The practice of the profession of pharmacy also includes the administration of vaccines to adults pursuant to s. 465.189.

(14) "Prescription" includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. The term also includes an orally transmitted order by the lawfully designated agent of such practitioner. The term also includes an order written or transmitted by a practitioner licensed to practice in a jurisdiction other than this state, but only if the pharmacist called upon to dispense such order determines, in the exercise of her or his professional judgment, that the order is valid and necessary for the treatment of a chronic or recurrent illness. The term "prescription" also includes a pharmacist's order for a product selected from the formulary created pursuant to s. 465.186. Prescriptions may be retained in written form or the pharmacist may cause them to be recorded in a data processing system, provided that such order can be produced in printed form upon lawful request.

(15) "Nuclear pharmacist" means a pharmacist licensed by the department and certified as a nuclear pharmacist pursuant to s. 465.0126.

(16) "Centralized prescription filling" means the filling of a prescription by one pharmacy upon request by another pharmacy to fill or refill the prescription. The term includes the performance by one pharmacy for another pharmacy of other pharmacy duties such as drug utilization review, therapeutic drug utilization review, claims adjudication, and the obtaining of refill authorizations.

(17) "Automated pharmacy system" means a mechanical system that delivers prescription drugs received from a Florida licensed pharmacy and maintains related transaction information.

(18) "Compounding" means combining, mixing, or altering the ingredients of one or more drugs or products to create another drug or product.

(19) "Outsourcing facility" means a single physical location registered as an outsourcing facility under the federal Drug Quality and Security Act, Pub. L. No. 113-54, at which sterile compounding of a

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drug or product is conducted. (20) "Compounded sterile product" means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug or product that is required to be sterile under federal or state law or rule, which is produced through compounding, but is not approved by the United States Food and Drug Administration.

History.--ss. 1, 7, ch. 79-226; s. 322, ch. 81-259; ss. 14, 15, ch. 81-302; ss. 2, 3, ch. 81-318; ss. 1, 2, ch. 82-179; s. 1, ch. 83-101; s. 36, ch. 83-216; s. 3, ch. 83-265; s. 29, ch. 83-329; s. 1, ch. 85-35; ss. 2, 26, 27, ch. 86-256; s. 1, ch. 88-172; s. 1, ch. 89-77; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 123, ch. 94-218; s. 239, ch. 97-103; s. 87, ch. 97-264; s. 118, ch. 99-397; s. 1, ch. 2002-182; s. 1, ch. 2004-25; s. 1, ch. 2004-387; s. 2, ch. 2007-152; s. 2, ch. 2012-60; s. 1, ch. 2014-148.

465.004 Board of Pharmacy.-- (1) The Board of Pharmacy is created within the department and shall consist of nine members to be appointed by the Governor and confirmed by the Senate. (2) Seven members of the board must be licensed pharmacists who are residents of this state and who have been engaged in the practice of the profession of pharmacy in this state for at least 4 years and, to the extent practicable, represent the various pharmacy practice settings. Of the pharmacist members, two must be currently engaged in the practice of pharmacy in a community pharmacy, two must be currently engaged in the practice of pharmacy in a Class II institutional pharmacy or a Modified Class II institutional pharmacy, and three must be pharmacists licensed in this state irrespective of practice setting. The remaining two members must be residents of the state who have never been licensed as pharmacists and who are in no way connected with the practice of the profession of pharmacy. No person may be appointed as a consumer member who is in any way connected with a drug manufacturer or wholesaler. At least one member of the board must be 60 years of age or older. The Governor shall appoint members to the board in accordance with this subsection as members' terms expire or as a vacancy occurs until the composition of the board complies with the requirements of this subsection. (3) As the terms of the members expire, the Governor shall appoint successors for terms of 4 years, and such members shall serve until their successors are appointed. (4) All provisions of chapter 456 relating to activities of the board shall apply.

History.--ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 3, 26, 27, ch. 86-256; s. 16, ch. 87-172; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 124, ch. 94-218; s. 88, ch. 97-264; s. 67, ch. 98-166; s. 124, ch. 2000-160; s. 1, ch. 2014-113.

465.005 Authority to make rules.-- The Board of Pharmacy has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter conferring duties upon it.

History.--ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 4, 26, 27, ch. 86-256; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91429; s. 126, ch. 98-200.

465.006 Disposition of fees; expenditures.-- All moneys received under this chapter shall be deposited and expended pursuant to the provisions of s. 456.025. All expenditures for duties of the board authorized by this chapter shall be paid upon presentation of vouchers approved by the executive director of the board.

History.--ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 26, 27, ch. 86-256; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91429; s. 68, ch. 98-166; s. 125, ch. 2000-160.

465.007 Licensure by examination.-- (1) Any person desiring to be licensed as a pharmacist shall apply to the department to take the licensure examination. The department shall examine each applicant who the board certifies has:

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(a) Completed the application form and remitted an examination fee set by the board not to exceed $100 plus the actual per applicant cost to the department for purchase of portions of the examination from the National Association of Boards of Pharmacy or a similar national organization. The fees authorized under this section shall be established in sufficient amounts to cover administrative costs.

(b) Submitted satisfactory proof that she or he is not less than 18 years of age and: 1. Is a recipient of a degree from a school or college of pharmacy accredited by an accrediting agency recognized and approved by the United States Office of Education; or 2. Is a graduate of a 4-year undergraduate pharmacy program of a school or college of pharmacy located outside the United States, has demonstrated proficiency in English by passing both the Test of English as a Foreign Language (TOEFL) and the Test of Spoken English (TSE), has passed the Foreign Pharmacy Graduate Equivalency Examination that is approved by rule of the board, and has completed a minimum of 500 hours in a supervised work activity program within this state under the supervision of a pharmacist licensed by the department, which program is approved by the board. (c) Submitted satisfactory proof that she or he has completed an internship program approved by the board. No such board-approved program shall exceed 2,080 hours, all of which may be obtained prior to graduation. (2) The department may permit an applicant who has satisfied all requirements of subsection (1), except those relating to age or the internship program, to take the written examination, but the passing of the examination shall confer no rights or privileges upon the applicant in connection with the practice of pharmacy in this state. (3) Except as provided in subsection (2), the department shall issue a license to practice pharmacy to any applicant who successfully completes the examination in accordance with this section.

History.--ss. 1, 7, ch. 79-226; ss. 13, 15, 23, 25, 30, 34, 62, ch. 80-406; ss. 2, 3, ch. 81-318; s. 30, ch. 83-329; ss. 5, 26, 27, ch. 86-256; s. 13, ch. 88-205; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 240, ch. 97-103.

465.0075 Licensure by endorsement; requirements; fee.-- (1) The department shall issue a license by endorsement to any applicant who applies to the department and remits a nonrefundable fee of not more than $100, as set by the board, and whom the board certifies: (a) Has met the qualifications for licensure in s. 465.007(1)(b) and (c); (b) Has obtained a passing score, as established by rule of the board, on the licensure examination of the National Association of Boards of Pharmacy or a similar nationally recognized examination, if the board certifies that the applicant has taken the required examination; (c)1. Has submitted evidence of the active licensed practice of pharmacy, including practice in community or public health by persons employed by a governmental entity, in another jurisdiction for at least 2 of the immediately preceding 5 years or evidence of successful completion of board-approved postgraduate training or a board-approved clinical competency examination within the year immediately preceding application for licensure; or 2. Has completed an internship meeting the requirements of s. 465.007(1)(c) within the 2 years immediately preceding application; and (d) Has obtained a passing score on the pharmacy jurisprudence portions of the licensure examination, as required by board rule. (2) An applicant licensed in another state for a period in excess of 2 years from the date of application for licensure in this state shall submit a total of at least 30 hours of board-approved continuing education for the 2 calendar years immediately preceding application.

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(3) The department may not issue a license by endorsement to any applicant who is under investigation in any jurisdiction for an act or offense that would constitute a violation of this chapter until the investigation is complete, at which time the provisions of s. 465.016 apply.

(4) The department may not issue a license by endorsement to any applicant whose license to practice pharmacy has been suspended or revoked in another state or who is currently the subject of any disciplinary proceeding in another state.

History.--s. 1, ch. 2001-166; s. 1, ch. 2008-216.

465.008 Renewal of license.-- (1) The department shall renew a license upon receipt of the renewal application, verification of compliance with s. 465.009, and receipt of a fee set by the board not to exceed $250. (2) The department shall adopt rules establishing a procedure for the biennial renewal of licenses. (3) Any person licensed under this chapter for 50 years or more is exempt from the payment of the renewal or delinquent fee, and the department shall issue a lifetime license to such a person.

History.--ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 6, 26, 27, ch. 86-256; s. 7, ch. 90-341; s. 59, ch. 91-137; s. 6, ch. 91156; s. 4, ch. 91-429; s. 178, ch. 94-119; s. 32, ch. 2001-277.

465.009 Continuing professional pharmaceutical education.-- (1) No license renewal shall be issued by the department until the licensee submits proof satisfactory to the board that during the 2 years prior to her or his application for renewal the licensee has participated in not less than 30 hours of continuing professional pharmaceutical education in courses approved by the board. (2) The board shall approve only those courses that build upon the basic courses offered in the curricula of accredited colleges or schools of pharmacy, and the board shall require that the provider meets the educational standards for the program design, administration, and evaluation established by the board. (3) Upon initial licensure, the department may reduce the number of required hours consistent with the requirements of biennial renewal. (4) The department may make exception from the requirements of this section in an emergency or hardship case. (5) The board may adopt rules within the requirements of this section that are necessary for its implementation, including a rule creating a committee composed of equal representation from the board, the colleges of pharmacy in the state, and practicing pharmacists within the state, whose purpose shall be to approve the content of each course offered for continuing education credit prior to the time such course is offered. (6) Notwithstanding subsections (1)-(5): (a) Each pharmacist certified to administer a vaccine or epinephrine autoinjection under s. 465.189 must complete a 3-hour continuing education course, which shall be offered by a statewide professional association of physicians in this state accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award (AMA PRA) Category I credit, on the safe and effective administration of vaccines and epinephrine autoinjection as part of biennial relicensure or recertification. This course may be offered in a distance-learning format and must be included in the 30 hours of continuing professional pharmaceutical education specified in subsection (1). (b) Each pharmacist must submit confirmation of having completed the course specified in paragraph (a) on a form provided by the board when submitting fees for license renewal.

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(c) Failure to comply with paragraphs (a) and (b) results in the revocation of the authorization for a pharmacist to administer a vaccine or epinephrine autoinjection under s. 465.189. Such authorization may be restored upon completion of such requirements.

History.--ss. 1, 7, ch. 79-226; ss. 2, 3, ch. 81-318; ss. 7, 26, 27, ch. 86-256; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91429; s. 241, ch. 97-103; s. 1, ch. 2002-184; s. 3, ch. 2012-60.

465.012 Reactivation of license; continuing education.-- (1) The board shall prescribe by rule continuing education requirements as a condition of reactivating a license. The continuing education requirements for reactivating a license shall be at least 15 classroom hours for each year the license was inactive in addition to completion of the number of hours required for renewal on the date the license became inactive. (2) The board shall adopt rules relating to application procedures for inactive status, to the biennial renewal of inactive licenses, and to the reactivation of licenses. The board shall prescribe by rule an application fee for inactive status, a renewal fee for inactive status, a delinquency fee, and a fee for the reactivation of a license. None of these fees may exceed the biennial renewal fee established by the board for an active license. The department may not reactivate a license unless the inactive or delinquent licensee has paid any applicable biennial renewal or delinquency fee, or both, and a reactivation fee.

History.--ss. 1, 7, ch. 79-226; s. 323, ch. 81-259; ss. 2, 3, ch. 81-318; ss. 2, 30, ch. 82-179; s. 3, ch. 83-265; ss. 8, 26, 27, ch. 86-256; s. 8, ch. 90-341; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 179, ch. 94-119.

465.0125 Consultant pharmacist license; application, renewal, fees; responsibilities; rules.-- (1) The department shall issue or renew a consultant pharmacist license upon receipt of an initial or renewal application which conforms to the requirements for consultant pharmacist initial licensure or renewal as promulgated by the board by rule and a fee set by the board not to exceed $250. The consultant pharmacist shall be responsible for maintaining all drug records required by law and for establishing drug handling procedures for the safe handling and storage of drugs. The consultant pharmacist may also be responsible for ordering and evaluating any laboratory or clinical testing when, in the judgment of the consultant pharmacist, such activity is necessary for the proper performance of the consultant pharmacist's responsibilities. Such laboratory or clinical testing may be ordered only with regard to patients residing in a nursing home facility, and then only when authorized by the medical director of the nursing home facility. The consultant pharmacist must have completed such additional training and demonstrate such additional qualifications in the practice of institutional pharmacy as shall be required by the board in addition to licensure as a registered pharmacist. (2) Notwithstanding the provisions of subsection (1), a consultant pharmacist or a doctor of pharmacy licensed in this state may also be responsible for ordering and evaluating any laboratory or clinical testing for persons under the care of a licensed home health agency when, in the judgment of the consultant pharmacist or doctor of pharmacy, such activity is necessary for the proper performance of his or her responsibilities and only when authorized by a practitioner licensed under chapter 458, chapter 459, chapter 461, or chapter 466. In order for the consultant pharmacist or doctor of pharmacy to qualify and accept this authority, he or she must receive 3 hours of continuing education relating to laboratory and clinical testing as established by the board. (3) The board shall promulgate rules necessary to implement and administer this section.

History.--s. 31, ch. 83-329; s. 1, ch. 85-65; ss. 9, 26, 27, ch. 86-256; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 1, ch. 93-231; s. 89, ch. 97-264.

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